Food Additives and Enzymes

Previously, food enzymes other than those used as food additives have not been regulated or have been regulated non-uniformly under individual Member State legislation. In December 2008, however, new legislation on food improvement agents was adopted in the EU which includes a regulation on food enzymes. This legislation came into force on 20 January 2010.

Regulation (EC) No 1331/2008 on food enzymes covers enzymes that are added to food to perform a technological function, including use as processing aids. The Regulation establishes a Community list of approved food enzymes. All new and existing food enzymes must undergo an authorisation procedure prior to inclusion on the Community list.

The information required for a dossier submission varies depending on the nature of the food enzyme, intended use, history of consumption and estimated exposure.

Intertek Cantox resources are extensive and include dedicated teams of experts in all areas of dossier preparation (regulatory, chemistry and manufacturing, intakes modeling, and toxicology). Let us facilitate rapid submissions to meet EFSA requirements and pre-empt regulatory concerns or questions.

Our services include:

• Identification of the appropriate regulatory strategy and data requirements for a submission;
• Conducting a feasibility assessment and providing recommendations for generation of information for identified technical and scientific data gaps;
• Preparing dossiers for submission to regulatory agencies for approval of use of an enzyme in the European Union; and
• Providing stewardship of applications through the complex scientific review by the European Food Safety Authority (EFSA) and regulatory procedures (The European Commission and Member States) to approval.